Phase I and pharmacokinetic study of the topoisomerase II catalytic inhibitor fostriecin
1999

Study of Fostriecin for Cancer Treatment

Sample size: 20 publication Evidence: low

Author Information

Author(s): Jong R S de, Mulder N H, Uges D R A, Sleijfer D Th, Höppener F J P, Groen H J M, Willemse P H B, Graaf W T A van der, Vries E G E de

Primary Institution: University Hospital Groningen

Hypothesis

Can fostriecin, a topoisomerase II inhibitor, be safely administered and show pharmacokinetic properties in cancer patients?

Conclusion

Fostriecin has a short plasma half-life and did not show significant tumor responses, but further dose escalation may be warranted.

Supporting Evidence

  • Fostriecin was administered intravenously over 60 minutes for five days at four-week intervals.
  • The predominant toxicities included elevated liver transaminases and serum creatinine.
  • Mean fostriecin plasma half-life was 0.36 hours initially and 1.51 hours terminally.
  • No tumor responses were observed in the study.

Takeaway

Doctors tested a new cancer drug called fostriecin to see how it works in the body, but it didn't help patients' tumors shrink.

Methodology

Fostriecin was given intravenously over 60 minutes for five days at four-week intervals, with dose escalation from 2 mg/m² to 20 mg/m².

Limitations

The maximum tolerated dose was not reached due to drug supply issues, and no tumor responses were observed.

Participant Demographics

Patients with small-cell lung cancer were included in the study.

Statistical Information

Confidence Interval

95% CI, 0–0.76 h (initial); 95% CI, 0.41–2.61 h (terminal)

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690141

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